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Court Finds Mifepristone REMS Unlawful

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A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.

Improving Cancer Trial Comparators: White Paper

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A Friends of Cancer Research working group suggests ways to overcome challenges in selecting standard of care comparators for onco...

Zydus Lifesciences FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Zydus drug manufacturing facility in Baddi, India.

Clinical Hold on 2 Intellia Gene Therapy Trials

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FDA issues a clinical hold on Intellia Therapeutics MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran after the co...

FDA Clears Tosohs Next-Generation HbA1c Analyzer

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FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) test...

Lantheus NDA for Imaging Agent Accepted

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FDA accepts for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotre...

FDA Drug Onshoring Policies Could Work: Attorneys

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Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufa...

Multiple Violations Seen in Contec Medical Inspection

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FDA warns Chinas Contec Medical Systems about Quality System and Medical Device Reporting violations in its manufacturing of sever...

FDA Signals Pragmatic Push to Ease Biosimilar Development

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FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the agency is focused on making biosimilar development...